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Last Updated: August 8, 2020

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Risperidone - Generic Drug Details

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What are the generic sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has ninety patent family members in twenty-eight countries.

There are thirty drug master file entries for risperidone. Thirty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for risperidone

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Drug Sales Revenue Trends for risperidone

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Recent Clinical Trials for risperidone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alen GrešEarly Phase 1
Shanghai Jiao Tong University School of MedicinePhase 4
University of RochesterPhase 2

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MG/MLSOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone
Medical Subject Heading (MeSH) Categories for risperidone
Paragraph IV (Patent) Challenges for RISPERIDONE
Tradename Dosage Ingredient NDA Submissiondate
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-04-11
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-03-23
RISPERDAL TABLET;ORAL risperidone 020272
RISPERDAL SOLUTION;ORAL risperidone 020588

US Patents and Regulatory Information for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising RISPERIDONE risperidone TABLET;ORAL 078269-002 Oct 8, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Indivior Inc PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655-002 Jul 27, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Pharm RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077494-001 Apr 30, 2009 RX No No   Start Trial   Start Trial   Start Trial
Indivior Inc PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655-002 Jul 27, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Celltrion RISPERIDONE risperidone TABLET;ORAL 078871-002 Oct 9, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007   Start Trial   Start Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-003 Apr 2, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for risperidone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196132 94C0008 Belgium   Start Trial PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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